# FDA 483 - Anacom General Corporation DBA Anacom MedTek - July 12, 2019

Source: https://www.globalkeysolutions.net/records/483/anacom-general-corporation-dba-anacom-medtek/f981f5eb-56b8-4cf9-adca-69d4f1f89dc7

> FDA 483 for Anacom General Corporation DBA Anacom MedTek on July 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anacom General Corporation DBA Anacom MedTek
- Inspection Date: 2019-07-12
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Anacom General Corporation DBA Anacom MedTek, a medical device manufacturer in Anaheim, CA, was cited with nine observations during an FDA inspection. The inspection revealed significant deficiencies across multiple quality system areas, including a lack of established procedures for finished device acceptance, incoming product acceptance, corrective and preventive actions, supplier control, complaint handling, nonconforming product control, and medical device reporting. Additionally, issues were noted with device history records and employee training documentation.

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/anacom-general-corporation-dba-anacom-medtek/8c9ac803-7101-473d-bb5f-d1c903f7b038

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6